Recall database

Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–3 of 3 recalls

Class IIOngoingZ-1585-2026

Diagnostica Stago, Inc. recalls Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF…

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

Control Antiserum Antigen Fibrinogen And Fibrin Split Products
Process change control

Diagnostica Stago, Inc…NJMar 25, 2026

Class IIOngoingZ-0731-2026

GET TESTED INTERNATIONAL AB recalls D-Dimer Test

Distribution without premarket approval/clearance.

Control Antiserum Antigen Fibrinogen And Fibrin Split Products
No Marketing Application

GET TESTED INTERNATION…Dec 10, 2025

Class IIOngoingZ-0205-2026

Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

Control Antiserum Antigen Fibrinogen And Fibrin Split Products
Under Investigation by firm

Diagnostica Stago, Inc…NJOct 22, 2025